[KJ-INT-002] BE Study

Gastritis Clinical Trial

Official title:

A Randomized, Open-label, Crossover Clinical Study to Assess the Safety and the Pharmacokinetic Characteristics of INT-2150 After Oral Administration to Healthy Adult Male Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03509831
• Other study ID #: KJ-INT-002
• Status: Active, not recruiting
• Phase: Phase 1
• First received: April 5, 2018
• Last updated: April 17, 2018
• Start date: November 2, 2017
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: Kukje Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assess the Safety and the Pharmacokinetic Characteristics of INT-2150 after Oral Administration to Healthy Adult Male Subjects

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 37
• Est. completion date: April 2018
• Est. primary completion date: January 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Male aged between 19 and 45 years of age inclusive, at the time of signing the informed consent.

2. Body weight >= 50 kilogram (kg) and body mass index within the range 18 - 29.0kg/m^2 (inclusive).

3. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.

4. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form

Exclusion Criteria:

1. Patients with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, muscloskeletal, immune, the nose and ears, psychiatry, stomach system.

2. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator contraindicates their participation.

3. Systolic blood pressure = 150 or = 100 mmHg, Diasolic blood pressure = 95 or = 55 mmHg.

4. Gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational product.

5. Alanine aminotransferase, alkaline phosphatase <=2x upper limit of normal (ULN) total bilirubin > 2.0mg/dl and eGRF <60mL/min/1.73m2

6. History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >21 units for males. One unit is equivalent to 10 gram of alcohol.

7. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 90 days of the biological effect of the investigational product (whichever is longer).

Related Conditions & MeSH terms

• Gastritis

Intervention

Drug:
• INT-2150
Period: INT-2150 Period: Irsogladine maleate 2 mg+Nizatidine 150 mg
• Irsogladine maleate 2 mg+Nizatidine 150 mg
Period: Irsogladine maleate 2 mg+Nizatidine 150 mg Period: INT-2150

Locations

Country	Name	City	State
Korea, Republic of	Kukje Pharm	Seongnam-si

Sponsors (1)

Lead Sponsor	Collaborator
Kukje Pharma

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCt	Pharmacokinetic Characteristics	One day
Primary	Cmax	Pharmacokinetic Characteristics	One day
Secondary	AUC8	Pharmacokinetic Characteristics	One day
Secondary	tmax	Pharmacokinetic Characteristics	One day
Secondary	t1/2	Pharmacokinetic Characteristics	One day